Full-Time
Lab Technician
Documentation Writer
Nivagen Pharmaceuticals
51-200 employees
Develops, acquires, and markets generic drugs
Compensation Overview
$25 - $27/hr
Sacramento, CA, USA
In Person
Must reside within ~40 miles of the Sacramento metro area.
 Content & Writing (1) |
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- High school/GED Degree.
- Experience in assisting in preparing reports and writing documents.
- Proficiency in Microsoft Office.
- Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles’ radius)
- Prepare, revise, and maintain analytical documents, including test methods and method validation protocols/reports; specifications, standard test procedures, standard operating procedures, control sheet, control worksheet and analytical procedures; change controls, deviations, CAPAs, and investigations; ensure documents comply with current good manufacturing practices, Food and Drug Administration regulations, International Council for Harmonisation guidelines, and internal quality standards.
- Manage document lifecycle activities using electronic quality systems.
- Create and route documentation through approval workflows in TrackWise and eInfoTree.
- Enter, review, and maintain analytical data and workflows in StarLIMS.
- Collaborate with quality control, quality assurance, research and development, and regulatory teams during document preparation and review.
- Support internal and external audits by providing accurate and compliant documentation.
- Maintain version control, archival, and traceability of analytical records.
- Perform any additional tasks as assigned by management.
Nivagen Pharmaceuticals develops, acquires, and sells generic prescription drugs and OTC products for the North American market. It leverages global partnerships with FDA-approved manufacturing facilities to deliver high-quality, affordable products and collaborates with the world’s best CROs and CRAMs to develop and manufacture niche generics. The company supports small FDA-qualified manufacturers entering the U.S. market and differentiates itself through its ability to launch new generic products and its strong sales and marketing team, rather than relying on a single manufacturing or development approach. Revenue comes from product development, co-development, acquisitions, in-licensing, and providing sales and marketing services. Nivagen aims to grow its portfolio by forging CRO/CRAM partnerships, acquiring existing products, and expanding its product lineup to capture a larger share of the evolving generic and OTC market in North America.
Company Size
51-200
Company Stage
Growth Equity (Venture Capital)
Total Funding
$26M
Headquarters
Sacramento, California
Founded
2009
Simplify's Take
What believers are saying
- PAI Pharma acquisition in January 2026 adds 20 injectables to PAI's 14 sterile products.
- Olympus-backed PAI bolsters domestic manufacturing amid ongoing FDA shortages.
- Expands CDMO and 503B services for institutional channels facing shortages.
What critics are saying
- FDA shuts Sacramento facility within 12 months over aseptic media fill violations.
- API costs from Aurobindo rise 25% in 3 months, forcing 20% price hikes.
- Levo captures 30% of $50M revenue via Paragraph IV filings in 12 months.
What makes Nivagen Pharmaceuticals unique
- Nivagen's 100,000 sq ft c-GMP facility in Sacramento produces IV bags, vials, prefilled syringes, cartridges.
- Over 20 RTU sterile injectables target persistent US hospital drug shortages.
- Global CDMO network in Europe and Japan enables cost-effective generics development.
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People at Nivagen Pharmaceuticals who can refer or advise you
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Paid Time Off
401 (k) savings plan
Growth & Insights and Company News
6 month growth
↓ -4%1 year growth
↓ -2%2 year growth
↓ -7%Olympus-backed PAI Pharma picks up Nivagen Pharmaceuticals. Headquartered in Greenville, South Carolina, PAI is a developer, manufacturer and marketer of oral liquid medicines. * Nivagen operates an aseptic manufacturing facility in Sacramento, California, designed to support the production of IV bags, vials, prefilled syringes, and cartridges * Nivagen was founded in 2009 PAI Pharma, which is backed by Olympus Partners, has acquired Nivagen Pharmaceuticals, Inc, a Sacramento, California-based pharmaceutical company. No financial terms were disclosed. Gain instant access to our expert editorial analysis and in-depth insight. Already have an account? Sign in.
PAI Pharma, a portfolio company of Olympus Partners, has acquired Nivagen Pharmaceuticals, a California-based pharmaceutical company specialising in ready-to-use sterile injectables. The deal expands PAI's domestic manufacturing capabilities and addresses persistent drug shortages in the US healthcare system. Nivagen operates a state-of-the-art aseptic manufacturing facility in Sacramento, producing IV bags, vials, prefilled syringes and cartridges. The company brings over 20 injectable products to complement PAI's existing sterile portfolio of approximately 10 products in development and four on the market. The acquisition aligns with growing efforts to reshore pharmaceutical production and reduce reliance on foreign supply chains. PAI Pharma was advised by Bourne Partners, Kirkland & Ellis and KPMG, whilst Olympus Partners provided backing for the transaction.
Corbel Capital Partners invested in Nivagen Pharmaceuticals (Sacramento, CA, US), a specialty pharmaceuticals business that develops and sells generic and branded prescription drugs.